A Single-Institution Case Series of Total Endovascular Relining for Type 3 Endoleaks in Traditional Endovascular Aneurysm Repair (EVAR) Grafts with Raised Bifurcations.

BACKGROUND: The endovascular repair of infrarenal abdominal aortic aneurysms can be performed with a wide variety of devices. Many of these grafts elevate the aortic bifurcation which can limit future repairs if the graft material fails thereby creating a type III endoleak to aorto-uniliac grafts. Many manufacturers have grafts susceptible to this, but we have seen this in the Medtronic AneuRx graft. Our goal is to provide technical details and outcomes regarding a novel technique to reline these grafts while maintaining inline flow to the iliac arteries. METHODS: This was a single-institution review of patients who had endoleaks requiring intervention after a previously placed graft with an elevated aortic bifurcation. Primary outcomes included technical success defined as placement of all planned devices, resolution of type III endoleak, aneurysm size at follow-up, and requirement of reintervention. Secondary outcomes included 30-day complications, aneurysm-related mortality, and all-cause mortality. Technical details of the operation include back-table deployment of an Ovation device, modification of the deployment system tether and pre-emptive placement of an up and over 0.014″ wire. The wire is placed up and over and hung outside the contralateral gate. Once the main body is introduced above the old graft, the 0.014" is snared from the contralateral side and externalized. The main body is then able to be seated at the bifurcation as the limb is not fully deployed and then device deployment is completed per instructions for use. RESULTS: Our study consists of 4 individuals, 3 of which had an abdominal aortic aneurysm initially managed with an AneuRx endovascular aneurysm repair and 1 with a combination of Gore and Cook grafts. All 4 patients were male with an average age of 84.5 years at time of reline. All patients had at least 10 years between initial surgery and reline at our institution. Primary outcomes revealed no type 1 or 3 endoleaks at follow-up, technical success was 100% and 1 patient required reintervention for aneurysm growth and type 2 endoleak. In terms of our secondary outcomes, there was 1 postoperative complication which was cardiac dysfunction secondary to demand ischemia, aneurysm-related mortality was 0% and all-cause mortality was 25% at average follow-up of 2.44 years. CONCLUSIONS: As individuals continue to age, there are more patients who would benefit from less invasive reinterventions following endovascular aneurysm repair. Whether this is due to aortic degeneration, stent migration, or stent material damage is not always known. In this study, we present an endovascular approach to treating type III endoleak patients with a previous graft and elevated aortic bifurcation using Ovation stent grafts and found no evidence of type 1 or 3 endoleaks on follow-up imaging. This approach may allow patients with type III endoleak the option of a minimally invasive, percutaneous approach where they previously would not have had one.

Upper Extremity Access Has Worse Outcomes in F/BEVAR Using the VQI Dataset.

BACKGROUND: Physician-modified endografts and custom-manufactured devices use branched and fenestrated techniques (F/BEVAR) to repair complex aneurysms. Traditionally, many of these are deployed through a combination of upper and lower extremity access. However, with newer steerable sheaths, you can now simulate upper extremity (UEM) access from a transfemoral approach. Single-institution studies have demonstrated increased risks of access site complications and stroke when UEM access is used. This study compares outcomes after F/BEVAR in a national database between total transfemoral (TTF) access and mixed UEM access. METHODS: This study is an analysis of the Vascular Quality Initiative for all patients who underwent F/BEVAR from 2014 to 2021. Patients were stratified based on a TTF delivery of all devices versus any UEM access for deployment of target vessel stents. Primary outcomes included stroke, myocardial infarction (MI), and perioperative death. Secondary outcomes included access site hematoma, occlusion or embolization, operative time, fluoroscopy time, and technical success. Multivariable linear and logistic regression analyses were performed. RESULTS: Three thousand one hundred forty six patients underwent an F/BEVAR: 2,309 (73.4%) TTF and 837 (26.6%) UEM. Logistic regression analysis indicated a two-fold increased risk of death and MI and a three-fold increased risk of stroke in the UEM group. Furthermore, there is decreased operative time (221 vs. 297 min, P < 0.001) and fluoroscopy time (62 vs. 80 min, P < 0.001) in the TTF group and no difference in technical success between groups (96% vs. 97%, P = 0.159). Finally, there was a decrease in access site hematoma 2.54% vs. 4.31% (P = 0.013), access site occlusion 0.61% vs. 1.91% (P = 0.001), and extremity embolization 2.17% vs. 3.58% (P = 0.026) in the TTF versus UEM group. CONCLUSIONS: This study using Vascular Quality Initiative data demonstrates that patients who undergo an F/BEVAR using UEM access have an increased risk of perioperative MI, death, and stroke compared to TTF access.

Prophylactic Perigraft Arterial Sac Embolization During EVAR: Minimizing Type II Endoleaks and Improving Sac Regression.

BACKGROUND: Type II endoleaks (ELII) are the most common complication following endovascular aneurysm repair (EVAR). Persistent ELII require continual surveillance and have been shown to increase the risk of Type I and III endoleaks, sac growth, need for intervention, conversion to open or even rupture, directly or indirectly. These are often difficult to treat following EVAR, and there are limited data regarding the effectiveness of prophylactic treatment of ELII. The aim of this study is to report the midterm outcomes of prophylactic perigraft arterial sac embolization (pPASE) performed in patients undergoing EVAR. METHODS: This is a comparison of 2 elective cohorts of those undergoing EVAR using the Ovation stent graft with and without prophylactic branch vessel and sac embolization. Patients who underwent pPASE at our institution had their data collected in a prospective, institutional review board-approved database. These were compared against the core lab-adjudicated data from the Ovation Investigational Device Exemption trial. Prophylactic PASE was performed at the time of EVAR with thrombin, contrast, and Gelfoam if the lumbar or mesenteric arteries were patent. Endpoints included freedom from ELII, reintervention, sac growth, all-cause mortality, and aneurysm-related mortality. RESULTS: Thirty-six patients (13.1%) underwent pPASE, while 238 patients (86.9%) had standard EVAR. Median follow-up was 56 months (33-60 months). The 4-year freedom from ELII estimates were 84% for the pPASE versus 50.7% for the standard EVAR group (P = 0.0002). All aneurysms in the pPASE group remained stable in size or demonstrated regression, whereas aneurysm sac expansion was seen in 10.9% of the standard EVAR group, P = 0.03. At 4 years, mean AAA diameter decreased by 11 mm (95% CI 8-15) in the pPASE group versus 5 mm (95% CI 4-6) for the standard EVAR group, P = 0.0005. There were no differences in the 4-year freedom from all-cause mortality and aneurysm-related mortality. However, the difference in reintervention for ELII trended toward significance (0.0% vs. 10.7%, P = 0.1). On multivariable analysis, pPASE was associated with a 76% reduction in ELII [(95% CI): 0.24 (0.08-0.65), P = 0.005]. CONCLUSIONS: These results suggest that pPASE in those undergoing EVAR is safe and effective in the prevention of ELII and significantly improves sac regression over standard EVAR while minimizing the need for reintervention.

TransCarotid Artery Revascularization Can Be Safely Performed in Patients Undergoing Dialysis.

BACKGROUND: TransCarotid Artery Revascularization (TCAR) has been effectively performed to prevent stroke in patients with carotid artery stenosis (CS). Prior studies established that TCAR can be safely performed in high-risk patients such as octogenarians, patients with prior carotid endarterectomy (CEA), contralateral occlusion, and heavily calcified lesions. Hemodialysis patients are at an increased risk of exhibiting cardiovascular complications. This study aims to investigate how dialysis may affect TCAR outcomes. METHODS: The Vascular Quality Initiative (VQI) dataset was queried for patients undergoing TCAR from November 2016 to November 2021. Patients were divided into dialysis and nondialysis groups. The primary outcome was the composite endpoint of in-hospital stroke, death, or myocardial infarction (MI). Secondary outcomes were in-hospital stroke, stroke, or transient ischemic attack (TIA), death, prolonged length of stay (more than 1 day) (PLOS), MI, and stroke or death. Multivariable logistic regression analysis was used to assess in-hospital outcomes. Kaplan-Meier survival and log-rank test were used to assess 1-year survival. RESULTS: A total of 22,619 patients underwent TCAR during the study period. Of these, 327 patients were undergoing dialysis. On univariable analysis, dialysis patients were associated with a higher risk of mortality compared to nondialysis patients (1.2% vs. 0.6%, P = 0.030). However, after adjusting for potential confounders, this difference did not persist (odd ratio [OR]: 1.99, 95% confidence interval [CI] (0.8-4.9), P = 0.136). Dialysis patients were more likely to experience PLOS (OR: 1.6, 95% CI (1.2-2), P < 0.001). There was no difference between dialysis and nondialysis patients in the risk of stroke or death, stroke, stroke or TIA, MI, and stroke or death, or MI on univariable and multivariable analyses. At 1 year, the overall survival for dialysis versus nondialysis patients was 81.5% vs. 95.5%, P < 0.001. CONCLUSIONS: To our knowledge, this is the first study to date of dialysis patients who have undergone TCAR. We have shown that there was no difference in the risk of stroke, death, and MI between dialysis and nondialysis patients. Therefore, TCAR can be safely offered to patients undergoing dialysis. Future studies with larger number of patients are warranted to confirm these results.

Use of surgical augmented intelligence maps can reduce radiation and improve safety in the endovascular treatment of complex aortic aneurysms.

OBJECTIVE: The introduction of endovascular procedures has revolutionized the management of complex aortic aneurysms. Although repair has traditionally required longer operative times and increased radiation exposure compared with simple endovascular aneurysm repair, the recent introduction of three-dimensional technology has become an invaluable operative adjunct. Surgical augmented intelligence (AI) is a rapidly evolving tool initiated at our institution in June 2019. In our study, we sought to determine whether this technology improved patient and operator safety. METHODS: A retrospective review of patients who had undergone endovascular repair of complex aortic aneurysms (pararenal, juxtarenal, or thoracoabdominal), type B dissection, or infrarenal (endoleak, coil placement, or renal angiography with or without intervention) at a tertiary care center from August 2015 to November 2021 was performed. Patients were stratified according to the findings from intelligent maps, which are patient-specific AI tools used in the operating room in conjunction with real-time fluoroscopic images. The primary outcomes included operative time, radiation exposure, fluoroscopy time, and contrast use. The secondary outcomes included 30-day postoperative complications and long-term follow-up. Linear regression models were used to evaluate the association between AI use and the main outcomes. RESULTS: During the 6-year period, 116 patients were included in the present study, with no significant differences in the baseline characteristics. Of the 116 patients, 76 (65.5%) had undergone procedures using AI and 40 (34.5%) had undergone procedures without AI software. The intraoperative outcomes revealed a significant decrease in radiation exposure (AI group, 1955 mGy; vs non-AI group, 3755 mGy; P = .004), a significant decrease in the fluoroscopy time (AI group, 55.6 minutes; vs non-AI group, 86.9 minutes; P = .007), a decrease in the operative time (AI group, 255 minutes; vs non-AI group, 284 minutes; P = .294), and a significant decrease in contrast use (AI group, 123 mL; vs non-AI group, 199 mL; P < .0001). No differences were found in the 30-day and long-term outcomes. CONCLUSIONS: The results from the present study have demonstrated that the use of AI technology combined with intraoperative imaging can significantly facilitate complex endovascular aneurysm repair by decreasing the operative time, radiation exposure, fluoroscopy time, and contrast use. Overall, evolving technology such as AI has improved radiation safety for both the patient and the entire operating room team.

One-year safety and effectiveness of the Alto abdominal stent graft in the ELEVATE IDE trial.

OBJECTIVE: This study reports the results of a prospective, multicenter trial designed to evaluate the safety and effectiveness of the polymer based Endologix Alto Stent Graft System in treating abdominal aortic aneurysms (AAAs), with sealing 7 mm below the top of the fabric in aortic neck diameters from 16 to 30 mm. METHODS: Seventy-five patients were treated with Alto devices between March 2017 and February 2018 in 16 centers in the United States for infrarenal AAAs (max diameter ≥5.0 cm in diameter or size increase by 0.5 cm in 6 months or diameter ≥1.5 times the adjacent normal aorta). Patients were followed for 30 days, 6 months, and 1 year by clinical evaluation and computed tomography and abdominal x-ray imaging. Treatment success was defined as technical success and freedom from AAA enlargement, migration, type I or III endoleak, AAA rupture or surgical conversion, stent graft stenosis, occlusion, kink, thromboembolic events, and stent fracture attributable to the device requiring secondary intervention through 12 months. Preoperative characteristics, perioperative variables, follow-up clinical evaluations, and radiographic examination results through the first 1 year were analyzed. RESULTS: The mean patient age was 73 years, with 93% of patients being male. The 30-day major adverse event rate was 5.3%. At 1 year, the primary endpoint was met with a treatment success rate of 96.7%. Through 1-year post-treatment, all-cause mortality was 4.0%. No AAA-related mortality occurred. AAA enlargement was 1.6%, type I endoleak rate was 1.4%, with 100% freedom from type III endoleaks, device migration, device fracture, stent occlusion, or AAA rupture. The device-related secondary intervention rate was 2.7%. CONCLUSIONS: This prospective study demonstrates the Endologix Alto is safe and effective in treating AAAs with appropriate anatomy at 1 year. The safety endpoint is met by a 5.3% 30-day major adverse event rate, whereas the effectiveness endpoint is met by a treatment success rate of 96%.

Surgery or Endovascular Therapy for Chronic Limb-Threatening Ischemia.

BACKGROUND: Patients with chronic limb-threatening ischemia (CLTI) require revascularization to improve limb perfusion and thereby limit the risk of amputation. It is uncertain whether an initial strategy of endovascular therapy or surgical revascularization for CLTI is superior for improving limb outcomes. METHODS: In this international, randomized trial, we enrolled 1830 patients with CLTI and infrainguinal peripheral artery disease in two parallel-cohort trials. Patients who had a single segment of great saphenous vein that could be used for surgery were assigned to cohort 1. Patients who needed an alternative bypass conduit were assigned to cohort 2. The primary outcome was a composite of a major adverse limb event - which was defined as amputation above the ankle or a major limb reintervention (a new bypass graft or graft revision, thrombectomy, or thrombolysis) - or death from any cause. RESULTS: In cohort 1, after a median follow-up of 2.7 years, a primary-outcome event occurred in 302 of 709 patients (42.6%) in the surgical group and in 408 of 711 patients (57.4%) in the endovascular group (hazard ratio, 0.68; 95% confidence interval [CI], 0.59 to 0.79; P<0.001). In cohort 2, a primary-outcome event occurred in 83 of 194 patients (42.8%) in the surgical group and in 95 of 199 patients (47.7%) in the endovascular group (hazard ratio, 0.79; 95% CI, 0.58 to 1.06; P = 0.12) after a median follow-up of 1.6 years. The incidence of adverse events was similar in the two groups in the two cohorts. CONCLUSIONS: Among patients with CLTI who had an adequate great saphenous vein for surgical revascularization (cohort 1), the incidence of a major adverse limb event or death was significantly lower in the surgical group than in the endovascular group. Among the patients who lacked an adequate saphenous vein conduit (cohort 2), the outcomes in the two groups were similar. (Funded by the National Heart, Lung, and Blood Institute; BEST-CLI ClinicalTrials.gov number, NCT02060630.).

A Single Center Review of a Total Transfemoral Approach to Upper Extremity Access in Branched and Fenestrated Physician Modified Endografts.

BACKGROUND: Aortic aneurysms are normally treated by an endovascular approach. Due to the lack of devices and increasing experience, there is a growing number of complex aneurysms undergoing repair by physician modified endografts (PMEGs). Previously, our practice was to target visceral vessels exclusively through upper extremity access. We have since then shifted to an all transfemoral approach when possible. This study aims to show the operative benefits of transfemoral only approaches. METHODS: Patients who underwent a PMEG at a tertiary center between 2015 and 2020 were included. Patients were stratified into 2 groups based on branched vessel approach-transfemoral only versus axillary or composite (axillary and femoral). Forty-one patients had a pararenal or type IV thoracoabdominal aortic aneurysm (TAAA) and 15 patients had more complex TAAA. Primary outcomes were operative time, radiation exposure, fluoroscopy time, contrast, and blood loss. Secondary outcomes were 30-day mortality and major adverse events. Linear regression models were used to evaluate the association between approach type and the main outcomes. RESULTS: Fifty-six patients were included with 48% (n = 27) in the transfemoral group and 52% (n = 29) in the axillary/composite group. Baseline characteristics were similar between the groups. Intraoperative outcomes revealed significant increase in the average operative time (418 vs. 246 min, P < 0.001), in radiation exposure (2,755 vs. 1,740 mGy, P = 0.03), in fluoroscopy time (108 vs. 74 min, P = 0.01) and in blood loss (579 vs. 202 cc, P = 0.002) in the axillary/composite group compared to the transfemoral group. There was no significant difference in 30-day mortality or major adverse events including stroke. CONCLUSIONS: This study shows a transfemoral approach to complex endovascular aortic aneurysm repair as opposed to axillary/composite approach has decreased operative time, radiation exposure, and fluoroscopy time and no significant differences in 30-day mortality or major adverse events. When treating complex aneurysms, improving efficiency is important to minimize morbidity to patients and operators.

"Aortic Balloon Molding" during Ovation Endograft Implantation Expands Graft Use for Hostile Neck Anatomy.

BACKGROUND: Challenging aortoiliac anatomy such as short neck and narrow access vessels is responsible for endovascular repair of abdominal aortic aneurysm (EVAR) ineligibility in up to 50% of cases. The Ovation stent graft helped widen the range of abdominal aortic aneurysms (AAAs) suitable for EVAR thanks to its low-profile delivery system and polymer-filled sealing rings. However, its advantages are offset by a tight sizing chart that can lead to increased risk of type Ia endoleak or endograft infolding from under- or oversizing, respectively. We sought to assess the safety and efficacy of a novel endovascular technique developed to expand the use of the Ovation endograft while avoiding these issues. METHODS: We conducted a retrospective review of all patients who underwent EVAR with the Ovation endograft at our institution between March 2019 and December 2020. "Aortic Balloon Molding" or ABM is a novel endovascular technique in which the graft is pre-cannulated and a compliant aortic balloon is inflated at the site of the graft's sealing rings during polymer administration. The technique was preferentially performed in patients with hostile neck anatomy (HNA) defined as any or all of angulation >60°, reverse taper configuration, ≥50% circumferential thrombus, or calcification. Patients undergoing traditional deployment were compared to those in whom ABM was performed. End points included neck-related adjunctive procedures, technical success, type Ia endoleak at completion angiogram, and 1-year freedom from type Ia endoleak and migration. RESULTS: A total of 43 patients were included in the study, of which 26 (60.5%) were treated with the ABM technique. Mean follow-up was 7.9 ± 6 months. Patients in the ABM group were more likely to have a reverse taper neck (61.5% vs. 41.2%, P = 0.1), have significant circumferential thrombus or calcium (23.1% vs. 5.9%, P = 0.1), and be treated outside of the Ovation indications for use regarding anatomic characteristics (65.4% vs. 41.2%, P = 0.1). Technical success was achieved in 100% of cases. However, patients in the ABM group were less likely to require a neck-related adjunctive procedure (7.7% vs. 23.5%, P = 0.1). Only 1 type Ia endoleak was observed at completion angiogram in a patient treated without ABM. At 1 year, freedom from type Ia endoleak or migration was 100% for both groups. CONCLUSIONS: ABM proves to be a safe and effective adjunctive technique for the treatment of AAAs with HNA using the Ovation stent graft. This may allow optimal endograft sizing to achieve adequate seal in complex aortic anatomies. Further research is warranted to evaluate the long-term outcomes of this technique.

Contemporary outcomes of limb-salvage procedures using Vascular Quality Initiative-Medicare-linked data: Racial and ethnic disparities persist.

BACKGROUND: Several reports have shown that ethnic and racial minority patients with chronic limb-threatening ischemia (CLTI) are more likely to undergo major amputation. Whether this disparity is driven by limited access to care, statistical discrimination, or biologic factors has remained a matter of debate. We studied the effects of race and ethnicity on the short- and long-term outcomes of limb-salvage procedures among patients with new-onset CLTI. METHODS: We identified all patients who had undergone first time (open or endovascular) revascularization for CLTI between January 2010 and December 2016 in the Vascular Quality Initiative-Medicare-linked database. These patients were divided into two groups: non-Hispanic White (NHW) and racial and ethnic minority (REM). The early end points included length of stay and operative mortality. The 2-year outcomes included major amputation, freedom from subsequent revascularization, number of limb salvage reinterventions, and all-cause mortality. Subanalyses comparing NHW and Hispanic patients and NHW and Black patients were also performed. RESULTS: Of 16,249 patients presenting with CLTI, 73.9% were NHW. The REM patients were younger (mean age, 69.9 ± 11.3 years vs 74.2 ± 10.5 years; P < .001) and more likely to be women (45.9% vs 37.7%; P < .001). Other baseline differences included a higher rate of smoking history, coronary artery disease, chronic obstructive pulmonary disease, and chronic kidney disease for the NHW group. In contrast, the REM patients were more likely to have diabetes and hypertension and were more likely to present with tissue loss (78% vs 76.6%; P = .04). The preoperative ankle brachial index and procedure type (endovascular vs open) were similar between the two groups. On multivariable analysis, the NHW group had had a 13% increase in the length of stay and a 25% decrease in operative mortality. Of the 2-year outcomes, the limb salvage estimate was 86% for the NHW group and 77.1% for the REM group (P < .001). A comparison between the two groups showed similar rates of freedom from subsequent revascularization (67.9% vs 67.1%; P =.2). The REM patients had had higher rates of overall survival (70.3% vs 68.4%; P = .01) compared with their NHW counterparts. The patients in the REM group were also more likely to have undergone more than two limb salvage reinterventions during follow-up (14.2% vs 8.6%; P < .001). After adjusting for potential confounders, the REM patients had significantly greater odds of major amputation at 2 years (adjusted hazard ratio, 1.49; 95% confidence interval, 1.36-1.63; P < .001). CONCLUSIONS: The results from the present Vascular Quality Initiative-Medicare-matched study have shown that REM patients continue to face a higher major amputation risk despite equivalent attempts at limb salvage. Further studies to identify the risk factors and evaluate intervention strategies that might be more effective in preventing amputation in this particular population are warranted.

The correlation of aortic neck length to late outcomes following EVAR with the Ovation stent graft.

OBJECTIVE: Endovascular aneurysm repair (EVAR) performed outside manufacturers' instructions for use due to short aortic neck for the treatment of abdominal aortic aneurysm (AAA) is associated with unfavorable outcomes. Newer endografts now have an indication for shorter neck aneurysms that previous endografts do not, but this cohort has yet to be evaluated individually. The aim of this study is to evaluate 5-year outcomes after EVAR in patients with short aortic necks (<10 mm) using the Ovation stent graft. METHODS: The study comprised 238 patients who underwent EVAR as part of the prospective international multicenter Ovation stent graft trials. The main inclusion criteria were AAA diameter ≥ 5 cm, proximal parallel neck length ≥7 mm, neck angulation ≤60°, and bilateral iliac fixation length ≥10 mm. A clinical events committee adjudicated adverse events through 1 year, an independent imaging core laboratory analyzed imaging through 5 years, and a data safety and monitoring board provided study oversight. Patients were divided into short neck (<10 mm) and standard neck (≥10 mm) groups. End points included long-term survival, freedom from aneurysm-related mortality (ARM), freedom from type Ia endoleak, and freedom from reintervention. RESULTS: Patients were predominantly male (81%) with a mean age of 73 ± 8 years. Median follow-up time was 58 months (interquartile range, 36-60 months). Of 238 patients, 41 (17.2%) had a proximal neck length <10 mm and would be considered outside the instructions for use with other stent grafts. Baseline characteristics were relatively similar between the two groups. The 5-year overall survival estimates were 77.8% for the standard neck group compared with 59.5% for the short neck group (P = .03). There were no differences in the 5-year freedom from ARM (99.2% vs 100%; P = .7), freedom from type Ia endoleak (96.3% vs 96.3%; P = .8), and freedom from reintervention (77.9% vs 79.7%; P = .7) between the standard and short neck groups, respectively. After adjusting for age and other potential confounders, short proximal neck was associated with a two-fold increase in 5-year all-cause mortality (adjusted hazard ratio, 2; 95% confidence interval, 1.02-3.8; P = .04]. CONCLUSIONS: The Ovation endograft performed well in short AAA neck with no difference in 5-year type Ia endoleak, reintervention, and ARM rates. However, short proximal neck was independently associated with a two-fold increase in the risk of all-cause mortality at 5 years. These findings confirm the prior literature on the association of hostile neck anatomy with late mortality following EVAR.

Polymer based endografts have improved rates of proximal aortic neck dilatation and migration.

BACKGROUND: Proximal aortic neck dilatation (PND) affects a considerable proportion of patients undergoing endovascular aneurysm repair (EVAR) and is associated with increased rates of type I endoleak (EL1), migration, and reinterventions. Although there are numerous studies investigating PND following the placement of endografts that utilize self-expanding stent (SES) technology, there are few reports for patients treated with endografts that utilize polymer-filled rings. The purpose of this study is to examine PND and graft migration after EVAR with the Ovation stent graft. METHODS: The study comprised patients who underwent EVAR as part of the prospective, international, multicenter Ovation stent graft trial. A clinical events committee adjudicated adverse events through 1 year, an independent imaging core laboratory analyzed imaging through 5 years, and a data safety and monitoring board provided study oversight. Neck diameter was measured at the level of the lowest renal artery. PND was defined as neck enlargement of 3 mm or more. Graft migration was defined as distal movement >10 mm or movement ≤10 mm when resulting in secondary intervention. RESULTS: A total of 238 patients received this device during the study period. Patients were predominantly male (81%), with a mean age of 73 ± 8 years. Median follow-up was 58 months (IQR 36-60). Almost half the patients (110 patients, 46%) had challenging anatomy; defined as outside the instructions for use (IFU) with other commercially available stent grafts. 41 patients (17.2%) had a proximal neck length <10 mm and 93 (39%) had a minimum access vessel diameter <6 mm. The technical success rate was 100%. The 1-, 3- and 5-year overall survival rates were 96.6%, 86.2% and 74.9%, respectively. The immediate postoperative proximal neck diameter ranged from 16 mm to 31 mm with a mean of 22.4 ± 3 mm. During follow-up, ten patients (4.2%) developed PND. Freedom from PND estimates at 1, 3 and 5 years were 97.7%, 96%, and 93.6%, respectively. None of the patients developed endograft migration. CONCLUSIONS: The use of the Ovation stent graft was associated with low rates of PND despite challenging neck anatomy in 17% of patients. No graft migration was observed. The design of this endograft may explain its superiority to SES in preventing neck dilatation and migration even in patients with challenging neck anatomy. This is important, as we continue to see significant late failures of EVAR due to proximal neck degeneration.

Prophylactic Aneurysm Embolization during EVAR Is Safe, Improves Sac Regression and Decreases the Incidence of Type II Endoleak.

BACKGROUND: Clinically significant endoleaks remain costly, time-consuming, morbid and even mortal following endovascular aneurysm repair (EVAR). Perigraft arterial sac embolization (PASE) has been utilized to treat type II endoleaks (T2EL) diagnosed at the time of EVAR or after repair. Our objective was to analyze the safety and efficacy of prophylactic PASE on the incidence of T2EL and aneurysm sac regression in patients undergoing EVAR. METHODS: We performed a retrospective review of prospectively maintained databases from the University of California San Diego and the San Diego Veterans Affairs hospitals between 2015 and 2019. Prophylactic PASE (pPASE) was performed at the time of EVAR with thrombin, contrast and gelfoam liquid embolic aneurysm treatment as previously described. We evaluated technical success, freedom from T2EL, freedom from reintervention, from sac expansion, from type I/III EL, from all-cause mortality (ACM), from aneurysm-related mortality and from non-target embolization (NTE). RESULTS: A total of 44 patients were included in the study. Technical success was 100% and no NTE was observed. The average duration of follow-up was 14 ± 11months. In those treated and followed by CT scan, 100% of patients' aneurysms halted their growth following PASE, while 65.9% demonstrated sac regression. Mean aneurysm sac diameter decreased by 9 mm (95% CI 7-12). At 3 years, freedom from T2EL was 87.1%. Presence of T2EL did not result in aneurysm expansion during the follow-up period and thus did not require reintervention in any of these patients. Freedom from re-intervention was 83.2% for Type Ib EL and limb occlusion and all procedures were determined to be successful at the time of completion. No aneurysm-related deaths occurred during the follow-up. CONCLUSIONS: PASE proves to be an effective tool in sac management for prophylaxis of endoleak and maximizing sac regression in EVAR. It is safe, effective and durable when employed in this manner in the short and medium-term and was associated with low rates of T2ELs and reinterventions and a 100% freedom from sac expansion. Further analysis is required to evaluate the long-term outcomes of this adjunctive procedure in EVAR.

Common Iliac Artery Aneurysm Repair with Hypogastric Preservation via Balloon-Expandable Covered Stents Using the Eyelet Technique-Iliac Branched Devices Still Inappropriate in Many Patients.

BACKGROUND: Common iliac artery aneurysms (CIAAs) are seen in 20-40% of patients with abdominal aortic aneurysms. Historically treated with sacrifice of the hypogastric artery, which can result in significant morbidity related to pelvic ischemia, new devices have made hypogastric artery preservation more feasible but are only applicable to a small subset of aneurysm anatomy. We sought to assess the safety and efficacy or a novel technique for hypogastric artery preservation applicable to a wider variety of patients with CIAAs. METHODS: We conducted a retrospective review of a prospectively maintained database of all patients with CIAAs treated with a novel endovascular technique at the UC San Diego Sulpizio Cardiovascular Center or the San Diego Veterans Affairs Hospital between March 2016 and December 2017. The endovascular technique involved stent placement in both the internal and external iliac arteries, with balloon expansion to minimize gutters between the endografts. Primary end points included technical success, limb patency, and presence of endoleaks (ELs). RESULTS: A total of 14 limbs (12 patients) were treated for CIAAs with 100% technical success and limb patency at an average of 6.8 months of follow-up. No patients experienced type I or type III ELs or evidence of pelvic ischemia. Two patients required reintervention, and one patient died of causes unrelated to the procedure. CONCLUSIONS: This technique was performed with excellent short- and mid-term safety in patients with varying aneurysm anatomy. The high rates of technical success and low rate pelvic ischemia represent improvement over conventional techniques that sacrifice the hypogastric artery and warrant further testing in a larger patient series with longer term follow-up.

Resurrection of Chronically Occluded Prosthetic Bypass Grafts in a Single Stage with Suction Thrombectomy and Intervention.

BACKGROUND: Peripheral arterial occlusive disease (PAOD) continues to be a vexing problem despite the advent of endovascular techniques augmenting traditional open repair. At our institution, we have found there is a growing number of patients with PAOD who are vein-challenged and have undergone prosthetic bypass previously for infrainguinal arterial reconstruction. When occluded, these grafts have been abandoned for a new bypass strategy or amputation. We present a novel technique of reestablishing flow through chronically occluded prosthetic bypass grafts. METHODS: A retrospective review of a prospectively maintained database compiled at 2 institutions between 2016 and 2019 was performed. Six patients had previous prosthetic bypass grafts with 4 patients having femoral to popliteal grafts, 1 patient with a femoral to femoral graft, and 1 with a femoral to posterior tibial bypass graft. All patients had an attempted single-stage intervention to clear chronically occluded grafts. RESULTS: A total of 6 patients were included in the study. Indications for intervention were chronic, critical limb ischemia with tissue loss (3), severe claudication (2), and acute on chronic limb ischemia (1). Average time from bypass to suction thrombectomy was 29 months (6-60 months). Mean patency duration is 13 months (1-28 months). Adjunctive procedures include overnight lysis to improve outflow in 1 patient (16.6%), drug-coated balloon angioplasty (83.3%), or stents (83.3%). There were no embolic complications during these procedures. All (2) wounds healed and all are maintained on full-dose anticoagulation and/or antiplatelet therapy. CONCLUSIONS: Often, the timing of bypass graft occlusion is unknown, and the risk of embolism with lysis for chronically occluded bypass grafts is concerning with traditional peripheral intervention techniques. We report a new and unique minimally invasive approach to resurrect chronically occluded prosthetic bypass grafts often successful in just one stage. This tool offers an alternative technique for limb salvage in complex patients and as use increases, requires further interrogation.

Poststent ballooning during transcarotid artery revascularization.

BACKGROUND: Poststent ballooning/angioplasty (post-SB) have been shown to increase the risk of stroke risk after transfemoral carotid artery stenting. With the advancement of transcarotid artery revascularization (TCAR) with dynamic cerebral blood flow reversal, we aimed to study the impact of post-SB during TCAR. METHODS: Patients undergoing TCAR in the Vascular Quality Initiative between September 2016 and May 2019 were included and were divided into three groups: those who received prestent deployment angioplasty only (pre-SB, reference group), those who received poststent deployment ballooning only (post-SB), and those who received both prestent and poststent deployment ballooning (prepost-SB). Patients who did not receive any angioplasty during their procedure (n = 367 [6.7%]) were excluded because these represent a different group of patients with less complex lesions than those requiring angioplasty. Primary outcome was in-hospital stroke or death. Analysis was performed using univariable and multivariable logistic regression models. RESULTS: Of 5161 patients undergoing TCAR, 34.7% had pre-SB only, 25% had post-SB only, and 40.3% had both (prepost-SB). No differences in the rates of in-hospital and 30-day stroke, death, and stroke/death were observed among the three groups; in-hospital stroke/death in the pre-SB group was 1.4% (n = 25), post-SB 1.2% (n = 16), and prepost-SB 1.4% (n = 29; P = .92). However, patients undergoing post-SB and prepost-SB had higher rates of in-hospital transient ischemic attacks (TIA) (post-SB, 0.9%; prepost-SB, 1% vs pre-SB, 0.2%, P < .01) and postprocedural hypotension (16.6% and 16.8% vs 13.1%, respectively; P < .001). Post-SB also had longer operative times, as well as flow reversal and fluoroscopy times. On multivariable analysis, no association was seen between post-SB and the primary outcome of in-hospital stroke/death (post-SB odds ratio [OR], 0.88; 95% confidence interval [CI], 0.44-1.73; prepost-SB OR, 0.98; 95% CI, 0.57-1.70). Similarly, no significant differences were noted in terms of postprocedural hemodynamic instability and 30-day outcomes. However, post-SB and prepost-SB were associated with four times the odds of in-hospital TIA compared with pre-SB alone (post-SB OR, 4.24 [95% CI, 1.51-11.8]; prepost-SB OR, 4.76 [95% CI, 1.53-14.79]; P = .01). Symptomatic patients had higher rates of in-hospital stroke/death compared with their asymptomatic counterparts; however, there was no significant interaction between symptomatic status and ballooning in predicting the primary outcome. CONCLUSIONS: Post-SB was used in 65.3% of TCAR patients. This maneuver seems to be safe without an increase in the odds of postoperative in-hospital stroke/death. However, the increased rates of TIA associated with post-SB requires further investigation.

Initial Results of Selected Use of Covered Stents in Transcarotid Artery Revascularization.

BACKGROUND: Transcarotid artery revascularization (TCAR) is a novel, hybrid approach to treating carotid disease in the treatment of stroke and stroke prevention. Early results of this hybrid approach to carotid stenting using flow reversal have been promising, with reported stroke rates around 1-2.8%.1,2 Currently, carotid stenting, regardless of approach, is performed with uncovered stents, which incurs the risk of plaque protrusion through the stent and in-stent restenosis. Overall, plaque protrusion is a rare event, with a reported incidence of 2.8% on angiography, but it is associated a high rate of ischemic complications (up to 66.7%).3 The use of covered stents could eliminate the risk of plaque protrusion and therefore short to midterm embolic phenomenon during the remodeling process. It also may improve rates of in-stent restenosis as it is a fully covered stent. Adoption of this technique has the potential to further improve the safety, efficacy, and durability of TCAR. METHODS: We performed a retrospective review of a prospectively maintained database of patients undergoing TCAR with covered stents between September 2018 and December 2019. Procedures were performed by the same operator at 2 separate institutions. Indications included severe asymptomatic or symptomatic carotid stenosis with high-risk lesions defined as lesions 2 cm lesions or longer and/or >50% of the lesion containing soft plaque or bleeding carotid pseudoaneurysm. Our primary outcomes included periprocedural and 30-day stroke rates. Secondary outcomes included stent patency and other procedure-related complications. All patients were maintained on clopidogrel postprocedure for 3 months and then transitioned to aspirin, unless otherwise indicated. RESULTS: A total of 6 patients underwent TCAR with covered stent angioplasty during this time period. Patient demographics included 5 males and 1 female, with an average age of 70.8 ± 4.6 years. Indications for stenting included 4 patients with asymptomatic >70% carotid stenosis and 1 patient with transient ischemic attack-like symptoms and >70% stenosis, and 1 patient with bleeding carotid pseudoaneurysm. Gore Viabahn covered stents were used in all patients. There were no periprocedural or postprocedural ischemic events at 30 days. All 6 stents remained patent at follow-up on duplex ultrasound, and all patients remained asymptomatic on clinical follow-up (average 3.4 [1.4-6.9] months). CONCLUSIONS: The use of covered stents for TCAR appears to be a safe and effective in select patients requiring carotid intervention. It holds the potential to decrease ischemic events from plaque protrusion and in-stent restenosis in the long-term. Further investigation in device design or clinical evaluation is warranted.

Midterm evaluation of perigraft arterial sac embolization in endovascular aneurysm repair.

OBJECTIVE: Management of clinically significant endoleaks (ELs) remains costly, time-consuming, and morbid. Unresolved ELs can result in rupture and mortality after endovascular aneurysm repair (EVAR). Perigraft arterial sac embolization (PASE) has been used to treat ELs diagnosed at the time of EVAR or during surveillance. METHODS: A retrospective review of prospectively maintained databases was conducted. The databases were compiled from two institutions between 2006 and 2016. PASE was performed for type I, type II, or type III EL with a thrombin, contrast medium, and Gelfoam (Pfizer, New York, NY) slurry prepared as previously described. PASE was administered either at the time of EVAR (primary) or during surveillance (secondary). Safety end points included nontarget embolization, defined as neurologic or enteric clinical sequelae from lumbar artery or visceral artery embolization, allergic reaction, peripheral embolization, or rupture. Efficacy end points included successful resolution of EL and cessation of aneurysm sac growth on computed tomography (CT) scans with contrast enhancement. RESULTS: A total of 66 patients included in the study were treated with PASE. Primary PASE was performed in 38 patients (58%) and secondary in 28 (42%). Within the total cohort, the average clinical and CT scan follow-up was 1.7 years (0.1-11.6 years). Four patients required open repair for residual high-pressure ELs (one type IIIB and three type I; 6%). Of the 95% of patients who did not require open conversion, aneurysm growth did not occur during the follow-up period. In the overall cohort, PASE was successful in 88% of type I EL and 73% of patients with type II EL. There was no evidence of recanalization after thrombosis of culprit vessel for EL. No patients suffered nontarget embolization, spinal ischemia, allergic reaction, post-EVAR rupture, or colonic ischemia. CONCLUSIONS: Primary and secondary PASE proved to be a safe, effective, and durable tool in sac management in conjunction with EVAR. Treating ELs during or after EVAR with PASE has minimized the incidence of EL on CT scan and halted aneurysm growth in our cohort. Further studies are needed to confirm the long-term durability of PASE in reducing secondary interventions after EVAR.

Long-term outcomes of the Ovation Stent Graft System investigational device exemption trial for endovascular abdominal aortic aneurysm repair.

OBJECTIVE: The objective of this study was to report the 5-year outcomes of the Food and Drug Administration investigational device exemption clinical trial of endovascular aneurysm repair (EVAR) with the Ovation stent graft (Endologix, Irvine, Calif) for elective treatment of abdominal aortic aneurysm (AAA). METHODS: The study comprised 161 patients who underwent EVAR as part of the prospective, international, multicenter pivotal Ovation stent graft trial. The main inclusion criteria were AAA diameter ≥5 cm, proximal neck length ≥7 mm, neck angulation ≤60 degrees, and bilateral iliac fixation length ≥10 mm. The primary end point was a composite outcome of primary clinical success at 5 years. Primary clinical success was defined in accordance with the Society for Vascular Surgery guidelines as successful aneurysm exclusion without aneurysm-related death, type I or type III endoleak, graft infection or thrombosis, aneurysm expansion, aneurysm rupture, graft migration, or conversion to open repair. Secondary end points included freedom from reintervention, all-cause mortality, and aneurysm-related mortality. RESULTS: Patients were predominantly male (87.6%) and elderly with a mean age of 73 ± 7.7 years; 66 patients (41%) had challenging anatomy and would be considered outside the instructions for use with other stent grafts, 26 (16.2%) had a proximal neck length <10 mm, and 53 (33%) had a minimum access vessel diameter <6 mm. Technical success was 100%. Of 126 surviving patients, 84 (66.7%) completed 5-year follow-up. The 5-year primary clinical success rate was 78%, aneurysm-related mortality was 1% (one patient), and all-cause mortality was 25%. The AAA-related death resulted from AAA post-EVAR rupture at 49 months in a patient who refused treatment for a type IB endoleak. Freedom from type I or type III endoleak was 95.1%. Freedom from secondary interventions was 80.2%. Most of the reinterventions were performed for type II endoleak (24 [63.1%]) or for limb thrombosis or stenosis (7 [18.4%]). There was no graft migration. None of the patients required open conversion. CONCLUSIONS: Five-year results from the Ovation pivotal and continued access investigational device exemption trials demonstrate excellent long-term durability of this endograft despite that 41% of patients had anatomy unfit for other stent grafts. There were no migrations or conversions to open repair and 99% freedom from aneurysm-related mortality. These results suggest a less invasive on-label endovascular option for patients with challenging anatomy who may otherwise require hybrid or open repair.

Novel Approach to Treatment of Chronic Iliocaval Occlusion Utilizing Covered Stents.

BACKGROUND: Chronic iliocaval obstruction is a challenging clinical entity to treat. Endovenous iliocaval stenting is becoming the treatment of choice for central vein stenosis and occlusion. However, outcomes in thrombotic disease have not been as robust as nonthrombotic disease. In this article, we describe our experience utilizing covered stents as a novel tool for chronic total occlusions of the iliocaval veins. METHODS: We performed a retrospective review of a prospectively maintained database of all patients undergoing endovenous stenting with a covered stent for chronic occlusive iliocaval disease over a 3-year period at our institution. Patients were followed clinically and with venous duplexes to assess the feasibility, safety, and outcomes of iliocaval endovenous stenting with covered stents. RESULTS: A total of 10 patients (8 men and 2 women) underwent iliocaval stenting with covered stents from July 2015 to May 2018. A total of 20 self-expanding covered stents (SECS) and 13 balloon expandable covered stents (BECS) were deployed in the central veins of the 10 patients. Six SECS and 5 BECS were deployed in the inferior vena cava, 10 SECS and 6 BECS were deployed in the common iliac veins (CIVs) (5 patients had bilateral CIV BECS and 2 patients had bilateral CIV SECS), and 4 SECS and 2 BECS were deployed in the external iliac veins (2 patients had bilateral SECS placed). Median follow-up time was 12.1 (range 0.5-35.0) months. There were no perioperative or postoperative complications. Nine (90%) patients maintained primary stent patency during our follow-up time. One patient (10%) had rethrombosis of his stent due to undertreated common femoral vein disease in the setting of a new myeloproliferative neoplasm and an inappropriate cessation of therapeutic anticoagulation. All patients who were symptomatic preoperatively had improvement in their pain, venous ulceration, and venous claudication. Eight of nine (89%) patients had improvement in their lower extremity edema. CONCLUSIONS: Covered endovenous stenting of chronically occluded central veins is a safe and promising procedure. Their use may improve the short- and long-term outcomes in this challenging patient population. Further studies are required to evaluate the long-term efficacy and cost of their use.